1. Field of the Invention
This invention relates to a method for forming and using a therapeutic device and, more particularly, to a method for forming and using a therapeutic device for an anatomical body portion with a thermal responsive medium.
2. Description of the Prior Art
Various ice packs, temperature maintaining devices, body warming devices, refrigerant packages, etc. are well known to perform either a heating or a cooling function, depending upon the nature of the device and the method of use in the treatment of trauma having an inflammatory response. These devices are adaptable for heating or cooling, as the case may be, various parts of the human body. For example, U.S. Pat. No. 2,589,577 to Rosenthal et al. discloses an ice pack formed of vinyl plastic sheeting. The ice pack has a plurality of chambers into which water or other suitable liquid is introduced through successive small passageways to fill the chambers with the requisite amount of liquid. The chambers are connected by welded areas. When the ice pack is frozen, the ice must be broken in order to bend the ice pack to the desired shape.
U.S. Pat. No. 3,463,161 to Andrassy discloses a temperature maintaining device in the form of a pad which may be used for heating or cooling. The pad includes two sheets of heat sealable flexible plastic material which are heat sealed to provide a plurality of relatively small compartments having barriers with restricted passages therebetween. The compartments are filled with a temperature retaining plastic composition by working the composition through the passages. One face of the pad may desirably have a layer of thermal insulating material applied thereto to minimize heat transfer to or from the pad through the pad's exposed face.
U.S. Pat. No. 3,506,013 to Zdenek discloses a method of making an iced dressing having one or more hermetically sealed compartments which are filled with a suitable liquid, such as water. In one embodiment, a plurality of separate subcompartments are separated from each other by longitudinal and lateral hinge portions. A plurality of communicating passages connect adjacent subcompartments to facilitate filling. The communicating passages are of relatively small size so that, when filled with a frozen material, they will readily break to allow folding along the respective hinge portions.
U.S. Pat. No. 2,562,121 to Poux discloses a therapeutic device for heating or withdrawing heat from parts of the human body. A plurality of permanently sealed compartments contain liquid with air-containing cells arranged therewith. The air-containing cells function as a cushioning or insulating means for the compartments containing liquid.
U.S. Pat. No. 2,648,325 to Siple discloses a body warmer having a heated liquid circulating system that includes a plurality of flexible tubes. The tubes have enlarged compressible bulbs integral therewith. Compression and expansion of the bulbs creates a pumping action causing the liquid to circulate. The body warmer is incorporated in a jacket and the action of breathing causes the compression and expansion of the bulbs. It is also disclosed that the device can be used to cool the body.
U.S. Pat. No. 1,627,523 to Morris discloses a face mask and cap. The cap has a sealable vent with a cap element. The vent communicates with tubing for admitting water to and withdrawing water from the tube. A suitable cloth or other absorbent material can be applied under the cap next to the head of the wearer.
U.S. Pat. No. 2,547,886 to Poux discloses a therapeutic device for use as an ice or hot water bag or pack having a loose mass of permanently sealed capsule-like members having a liquid therein. The capsule-like members are disposed within a permanently sealed hollow body member or within a plurality of permanently sealed independent compartments within an elongated body member. Water is preferably used as the liquid within the permanently sealed capsule-like members.
U.S. Pat. No. 2,602,302 to Poux discloses a combination ice and hot pack having a plurality of independent and sealed fluid-containing compartments. The compartments are spaced from each other by a relatively thin, flat and wide web of material allowing flexibility.
U.S. Pat. No. 3,075,529 to Young, Jr. discloses a therapeutic heat transfer device for temperature control of a human body. In one embodiment the device has a plurality of compartments formed by longitudinal and transverse welds. The compartments are filled with a thixotropic mixture.
U.S. Pat. No. 3,149,943 to Amador discloses a chemical refrigerant package for use as an ice pack. An envelope is divided into two compartments. One compartment is filled with a dry refrigerating substance, and the other compartment is filled with water or other suitable fluid. The compartments are initially sealed from each other. When the seal is eliminated, the contents of the compartments mix, producing an endothermic chemical reaction thereby reducing the temperature of the water or other suitable fluid.
U.S. Pat. No. 3,429,315 to McDonald discloses a chemical refrigerant blanket for cooling large areas of the body. The refrigerant blanket has a plurality of elongated chambers. Each chamber is divided into two compartments, one of which contains a granular material or endothermic salt and the other compartment contains a fluid. A clamping means separates the two compartments. When the clamping means is removed, the fluid and the granular material mix, producing an endothermic reaction which reduces the temperature surrounding the blanket.
U.S. Pat. No. 3,950,789 to Konz et al. discloses a dry ice cooling jacket which provides cooling by convection as carbon dioxide gas circulates within the space between the jacket's inside surface and the body of the wearer.
U.S. Pat. No. 4,044,773 to Baldwin, III discloses a cold therapeutic package and a method of using a cold therapeutic package. In Baldwin, two sheets of polyurethane film are sealed together to provide a hollow interior which is filled with a fluid, such as water. The hollow interior is designed such that the water therein can be frozen into a thin layer which can be readily cracked and fragmented into small ice pieces. The therapeutic package having the cracked ice therein is then applied to the area to be treated.
Various cellular materials for cushioning and insulating applications are known, as well as methods and apparatus for making the cellular material. For example, U.S. Pat. No. 3,415,711 to Chavannes discloses a cushioning and insulating material formed of at least two layers of plastic material. At least one of the layers of plastic material has discrete embossments. The side walls of the embossments are fused to the side walls of adjoining embossments to provide a pair of spaced layers of plastic material with a honeycomb structure of air cells between the layers.
U.S. Pat. No. 3,346,438 to Chavannes discloses a method and apparatus for making cushioning and insulating material wherein a plurality of hermetically sealed air pockets are joined, one to another, forming a sealed honeycomb structure. In the method, a first plastic film is heated and molded to provide a plurality of closely spaced embossments. A second plastic film is heated to a fusing temperature and fed, in overlying relationship with the unembossed portions of the first film. Thus the films are fused together to form a unitary structure having a plurality of closely spaced, hermetically sealed air pockets. The embossed surface of the unitary structure is heated to the melting point of the plastic films. The heated structure is compressed to fuse the side walls of adjoining embossments to one another. The resultant cushioning material is then cooled.
U.S. Pat. Nos. 3,285,793 and 3,392,081 to Chavannes disclose a multi-laminate cushioning material having two composite layers of plastic material. At least one of the layers is embossed and the other layer is sealed to the embossed layer forming a plurality of sealed air cells.
While it is well known to use various therapeutic devices as above discussed in the treatment of inflammatory type injuries to soft tissues, including muscles, tendons, and ligaments, the known devices are limited in their effectiveness in applying either heat or cold to the affected area of the body. The principal limitations are maintaining the device in place without discomfort and conforming the device to the body part in compression.
Therefore, there is needed a therapeutic device which can adequately conform to a body portion for use in hot or cold temperature applications. The therapeutic device must promote uniform distribution of heat transfer to or from the body portion under either hot or cold temperature applications, respectively. This requires that the device apply uniform compressive forces over the body part to promote rapid heat transfer. Additionally, a therapeutic device is needed which promotes a rapid reduction or increase in body surface temperature over a relatively short time period while minimizing discomfort.
Further, a therapeutic device is needed for the application of heat treatment which promotes a substantially uniform heat transfer to the body portion while minimizing discomfort and without damaging the skin of the body portion being treated.